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Proteasome inhibitors have become key drugs in the targeted therapy of multiple myeloma in current clinical applications. Based on the publicly available information on the domestic and foreign official websites of drug regulatory authorities regarding currently marketed proteasome inhibitor drugs, such as bortezomib for injection, carfilzomib for injection, and ixazomib citrate capsules, this article proposes the key points of attention in the research of drug substances and drug products for these three agents in pharmaceutical development, in order to promote the marketing of generic drugs.

, authors=Xin-zhu NA, Jian-zhen LIU, Jun-lin ZHANG, authorsList=Xin-zhu NA, Jian-zhen LIU, Jun-lin ZHANG, authorCompany=null, correspAuthors=Jun-lin ZHANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292126382524486430, articleId=1292126382138610460, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=多发性骨髓瘤蛋白酶体抑制剂类化学仿制药药学研究考虑, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

多发性骨髓瘤的靶向治疗中蛋白酶体抑制剂已成为当前临床应用的关键药物。本文根据目前已上市的蛋白酶体抑制剂类药物中注射用硼替佐米、注射用卡非佐米、枸橼酸伊沙佐米胶囊在国内外药监局官方网站公开信息等，提出了三个产品在药学研发中原料药和制剂研究的关注点，以促进仿制药的上市。

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那馨竹（1989-），女，助理研究员，主要从事化学仿制药审评工作

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那馨竹（1989-），女，助理研究员，主要从事化学仿制药审评工作

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